MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN SAPPHIRE SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	08H00-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased white blood cell (wbc) results on cell-dyn sapphire analyzer for one patient.The results provided were: on (b)(6) 2023 sid (b)(6) initial wbc=0.572 10e3/ul /repeated=4.40 10e3/ul; neutrophil abs=0.254 10e3/ul /repeated=2.07 10e3/ul.There was no reported impact to patient management.
Additional Manufacturer Narrative
During the requested site visit, the field service engineer (fse) performed and found that the pinch valve in the wbc reagent delivery pathway was broken.The pinch valve (valve, pinch,.06 inch id no, list number 8921184002), pinch tubing (kit tubing pinch (b)(6), and peristaltic pump tubing (perist pmp tbg-md, list number 91485-01, lot number 82271544) were replaced.Field service reported that the issue was not resolved until the white peristaltic pump tubing was replaced with yellow tubing from lot number 5315433553.The analyzer reports for initial run and rerun of sid (b)(6), were submitted for review illustrating the complaint issue of discrepant, low wbc and neu results.The returned condition of these tubing suggests that they were not replaced properly according to the "procedures for replacing sample transfer pump tubing" in section 9, "service and maintenance" of the cell-dyn sapphire.A review of all complaints associated with the perist pmp tbg-md, list number 91485-01, lot number 82271544, and a review for complaint trends for the list and lot numbers was performed.The review identified trend was not related to the complaint issue.Increased complaint activity related to complaint issue of low or blank results was not identified.The new revision, white, peristaltic pump tubing (list number 91485-01, rev f) was released on 12/05/2022.A review of the product historical data did not find a product issue related to the complaint.Labeling was reviewed and found to be adequate for the complaint issue.Based on the available information no product deficiency of the perist pmp tbg-md, or cell dyn sapphire analyzer, serial number (b)(6), was identified.
Event or Problem Description
The customer observed falsely decreased white blood cell (wbc) results on cell-dyn sapphire analyzer for one patient.The results provided were: on (b)(6) 2023 sid (b)(6) initial wbc=0.572 10e3/ul /repeated=4.40 10e3/ul; neutrophil abs=0.254 10e3/ul /repeated=2.07 10e3/ul there was no reported impact to patient management.

• Brand Name: CELL-DYN SAPPHIRE SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16753443
• Report Number: 2919069-2023-00013
• Device Sequence Number: 18274832
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 08H00-01
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown